MAUDE Adverse Event Report: BECTON DICKINSON & CO. ENRICHED THIOGLYCOLLATE MEDIUM; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 221788

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Enriched thioglycollate broth obtained from beckton dickinson and company was found to be contaminated with non-viable gram negative rods.This broth is used for wound , tissue, and sterile body fluid cultures.The gram negative rods showed up on gram stain which were then reported.Another case received on (b)(6) 2023 was also found to be contaminated.Bd was notified of the issue, case no.(b)(4).Hospital infection control and risk management teams were also notified.Cultures were set up between 1/9/2023 - 1/12/2023.Further investigation is in process to determine if any other patients were affected.

• Brand Name: ENRICHED THIOGLYCOLLATE MEDIUM
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 16247083
• MDR Text Key: 308254292
• Report Number: MW5114512
• Device Sequence Number: 2
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/06/2023
• Device Catalogue Number: 221788
• Device Lot Number: 2251073
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other